| CTRI Number |
CTRI/2020/04/024530 [Registered on: 08/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of migraine through Gandharyadi ghrita nasya and Goghrita nasya. A comparative study. |
|
Scientific Title of Study
|
A controlled comparative clinical study to evaluate Gandharyadi ghrita nasya and Go ghrita nasya in the management of Ardhavabhedaka w.s.r to Migraine. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parwati |
| Designation |
PG scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
7th floor, Academic block,
Dept of Panchakarma.
South West
DELHI
110076
India |
| Phone |
7503822981 |
| Fax |
|
| Email |
drparwatipingolia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SH Acharya |
| Designation |
DISTINGUISH PROFESSOR |
| Affiliation |
All India Institute of Ayurveda |
| Address |
7th floor, Academic block, Department of Panchakarma
South West
DELHI
110076
India |
| Phone |
9879550157 |
| Fax |
|
| Email |
dracharyadr@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh kumar Bhatted |
| Designation |
Associate Professor and Head |
| Affiliation |
All India Institute of Ayurveda |
| Address |
7th floor, Academic block, Departmrnt of Panchakarma
South West
DELHI
110076
India |
| Phone |
8851939675 |
| Fax |
|
| Email |
santoshbhatted@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of Ayurveda, Sarita Vihar, New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Kumar Bhatted |
All india institute of Ayurveda |
Opd-6, department of panchakarma, All India institute of Ayurveda
South West
DELHI |
8851939675
santoshbhatted@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasya with Gandharyadi ghrita in the forenoon in the dose of Eight drops in each nostrils for two courses of 7 days each
shamana oushadha as Narikela khanda-10gm bid with milk for 15days |
for first two day koshtha suddhi will be done by Triphala churna-5gm at bed time.
nasya with Gandharyadi ghrita-8drops in each nostrils at afternoon for 7 days.
then rest for 7 days.
again Nasya with Gandharyadi ghrita-8drops in each nostrils for 7days.
Internal medication with Narikela khanda-10gm B.D. with milk for 15 days. |
| Comparator Agent |
Nasya with suddha Go ghrita in both nostrils in the forenoon with a dosage of Eight drops to each nostrils for 7 days in 2 sitting.
shamana oushadha as Narikela khanda |
for first two days koshtha suddhi with Triphala churna-5gm at bedtime.
Nasya with Goghrita-8drops in each nostrils at afternoon for 7days.
then rest for 7 days.
Again Nasya with Goghrita-8drops in each nostrils for 7days.
Internal medication with Narikela khanda-10gm B.d with milk for 15days. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of Ardhavabhedaka , 1) Ardha parshwa Shirashoola– unilateral headache
2) Bheda , Toda, Shoola- pulsating , throbbing type of pain
3) Pakshat, Dashahat ,Akasmat- paroxysmal episodes.
4) Prakasha Asahishnata- photophobia, Nausea (Hrillas), vomiting (Chardi).
5) phonophobia |
|
| ExclusionCriteria |
| Details |
Known cases of Secondary headache caused by sinusitis , meningitis , brain tumour, increased intra ocular pressure , malignant HTN. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Response in headache |
Assesment will be done on baseline, 23day, 38day and 53day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement in quality of life. |
assesment will be taken on baseline, on 23,38day and 53 day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
outcomes will be published after trial in peer reviewed journal for wider dissemination. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Migraine is a
complex neurological disorder that manifests
with recurrent headache, nausea, vomiting, photophobia or phonophobia. The
prevalence of migraine is 15% to 20% in women and
4% to 7% in men. In children the prevalence may be as high as 17% and is
equal in boys and girls. The highest prevalence occur between
the ages of 25yrs and 55 yrs. Based on sign
and symptoms of Ardhavabhedaka. It can be
compared with migraine. Objective of this study is to compare the
efficacy of Gandharyadi ghrita nasya and Go ghrita nasya along with internal
medication as Narikela khanda in the management of Ardhavabhedaka. Study will conduct in AIIA hospital with taken 15
patients in each groups by block randomization. Diagnosis of patient will be
done according Intrernational headache society for migraine. Primary assessment
parameter will pain and secondary will quality of life. Total duration of this
study will be 53days.
|